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Amgen’s adalimumab biosimilar will only be launched in US in 2023

US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

EMA accepts application for pegfilgrastim biosimilar from Cinfa

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 4 October 2017 that its application for approval for its proposed pegfilgrastim biosimilar (B12019) had been accepted by the European Medicines Agency (EMA).

Nichi-Iko gains Japanese approval for infliximab biosimilar

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.

JCR files for Japanese approval of agalsidase beta biosimilar

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for its agalsidase beta biosimilar (JR‑051).

FDA accepts application for Adello’s filgrastim biosimilar

US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for its proposed filgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

EMA approval for adalimumab and trastuzumab biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Cyltezo and the trastuzumab biosimilar Ontruzant.

FDA accepts application for rituximab biosimilar from Sandoz

Sandoz, the generics division of Novartis, announced on 12 September 2017 that the regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the US Food and Drug Administration (FDA).

FDA approves bevacizumab biosimilar Mvasi

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Second etanercept biosimilar approved in Canada

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

Sanofi receives tentative FDA approval for insulin lispro biosimilar

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).

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